The Fastep COVID-19 Antigen Pen Home Test is for FDA Emergency Use Authorization (EUA) only:
Fastep COVID-19 Antigen Pen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two (2) years or older
This test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests
Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status; positive results do not rule out bacterial infection or co-infection with other viruses
All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed
Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks; negative results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19
All healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC
The Fastep COVID-19 Antigen Pen Home Test is a single test comprised of a base and a test pen with an integrated sample swab and test strip
Each Fastep COVID-19 Antigen Pen Home Test has a built-in internal procedural control
Product Specs
Item Number
1273391
Catalog Number
COV-S35001H2
UOM
CS
Level 1 Family Description
Lab-Waived Lab
Level 2 Category Description
Lab-Rapids
Level 3 Group Description
Other Visual Rapids
Level 4 Sub-Category Description
Miscellaneous Visual Rapids
Application
Respiratory Test Kit
Brand
FaStep
Buy American Act (BAA) Compliant
No
Contents 1
Each Kit contains (2) Foil Packages with Base and Test Pen, Package Insert